UMIN-CTR Clinical Trial

Public title

Research for effectiveness and safety of branched stent-graft to aortic arch disease

Acronym

Research for effectiveness and safety of branched stent-graft to aortic arch disease

Scientific Title

Research for effectiveness and safety of branched stent-graft to aortic arch disease

Scientific Title:Acronym

Research for effectiveness and safety of branched stent-graft to aortic arch disease

Region

Japan

Condition

aortic arch disease

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

to evaluate the effectiveness and safety of branched stent graft to aortic arch disease

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

freedom from aortic rupture/enlargement at 6 month postoperatively

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Endovascular arotic repair

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) aortic aneurysm located aortic arch to descending aorta and the following one of features are admitted:.
1-a) the largest diameter exceeds 50mm in fusiform aneurysm
1-b) saccular aneurysm containing the risk of rupture
1-c) rapid expansionary more than 5mm/ year
1-d) symptomatic
1-e) risk of rupture or malperfusion
2) the patient who judges the average artificial blood vessel substitution way dies of more than one cardiovascular surgery medicine or, a possibility of the severe complication development is high, and that it's difficult to enforce safely.
3) treatment in aorta stentgraft approved at present doesn't possess more than 20 mm of normal blood vessel in the left common carotid branch part end, and is difficult.
I possess an aorta neck of diameter 18 suitable for stentgraft custody-42 mm in a line aorta on the 4).
5) I possess enough blood vessel access for delivery system [biggest outside diameter 26Fr (8.7 mm)] insertion.
6) after a subject had the explanation about the contents of this research, I'm signing agreement sentences.
7) an examinee and the doctor who does this research agree about that a subject goes to a hospital on all follow up days when it's necessary after hand skill operation.

Key exclusion criteria

1)underage (less than 20). 2)a untreated coronary artery disease 3)severe LV dysfunction(LVEF is less than 20%) 4)the patient with pregnancy. 5)the following one of haematological disorder.
(1)Leukocyte decrease (a leukocyte, several 1000 /mm3, less than)(2)Platelet decrease shou (a platelet, several, 50,000 /mm3, less than)(3)Haemorrhagic diathesis or blood clotting abnormality. 6)the morbid overweight patient who can't take a picture of an X-ray picture of an aorta appropriately. 7)chronic obstructive pulmonary disease which requires O Ther outside the hospital daily (COPD) is admitted. 8)it's following hyperesthesia to whether it's both or taboo, and it can't be treated appropriately beforehand.(1)Contrast medium(2)NICHINORU (titanium and nickel alloy), platinum iridium base alloy and polyester(3)Heparin
9)an active whole body infection and/or, patient with infectibility big aneurysm. 10) the past of the cerebrovascular accident (CVA) or a transient brain ischemia attack (TIA) is within 1 month old from a schedule operation day. 11)active enteron bleeding. 12)the patient diagnosed as life expectancy for less than 1 year based on a clear basis (existence of malignant tumor and aging) medically. 13)the patient who participates in a clinical trial of other medical equipment or medical supplies. 14)it seems to refuse blood transfusion. 15)serious recognition shou (As a result, it isn't possible to do the life which became independent outside the Long Term Care Facility to which an agreement explanation note can't be submitted or a hand skill and going to a hospital for follow-up won't be done for a rehabilitation.) 16)the patient who judged a doctor in attendance when it was medical to participate in clinical study psychologically and was difficult.
(anatomilcal contraindication)
beyond information for use

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Hideyuki Shimizu

Organization

Keio University School of Medicine

Division name

Department of Cardiovascular Surgery

Zip code

Address

35 Shinanomachi, Shinjuku, Tokyo 160-8582, JAPAN

TEL

03-3353-1211

Email

hideyuki@keio.jp

Name of contact person

1st name
Middle name
Last name	Akihiro Yoshitake

Organization

Keio University School of Medicine

Division name

Department of Cardiovascular Surgery

Zip code

Address

35 Shinanomachi, Shinjuku, Tokyo 160-8582, JAPAN

TEL

03-3353-1211

Homepage URL

Email

akihiro197253@yahoo.co.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Keio University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

03

Month

08

Day

Date of IRB

Anticipated trial start date

2016

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

03

Month

11

Day

Last modified on

2017

Year

06

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024698